About this trial
The goal of this study is to learn if the TGFR device (which uses telmapirazin to continuously measure real-time GFR) works to provide accurate and dynamic kidney function assessment in critically ill adults with acute kidney injury (AKI). It will also learn how tGFR compares with the gold standard measured GFR (mGFR) and other commonly used estimate methods. The main questions it aims to answer are:
* Does tGFR show good agreement with mGFR over the 0-12 hour period in AKI patients? * How do tGFR, mGFR, 4-hour creatinine clearance, kinetic GFR (keGFR), and CKD-EPI eGFR compare across different AKI stages? * What are the bias and variability of each method over time?
Researchers will compare tGFR to mGFR (iohexol clearance) to see if tGFR is a reliable alternative for bedside, continuous GFR monitoring. They will also compare tGFR against 4-hour creatinine clearance, keGFR, and eGFR to assess consistency across AKI stages.
Participants will:
* Wear a single-use tGFR sensor patch on the chest for continuous GFR monitoring * Receive iohexol injection for mGFR measurement (gold standard) * Provide blood and urine samples for 4-hour creatinine clearance and other tests * Undergo repeated GFR assessments over the 12-hour study period
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
CU stay ≤ 72 hours;
meets KDIGO AKI criteria;
age 18-85 years;
able to complete blood/urine collection and monitoring
Disqualifiers
prior history of CKD stage 4 or higher;
anuria;
recent contrast agent exposure or kidney transplant history;
pregnancy or breastfeeding; expected survival < 24 hours.
Trial design
Single group
Treatments tested in this trial
transdermal GFR
DeviceThe tGFR detection system comprised 3 distinct components as follows: (i) the fluorescent tracer agent, Lumitrace, (ii) a single small module containing both the light source and photo detector attached to the upper chest area using a biocompatible adhesive, and (iii) a display monitor that digitizes the acquired fluorescent intensity data and contains the algorithms to convert these data to GFR. Background endogenous fluorescence was acquired after attachment of the module to the chest, followed by a 7 ml i.v. bolus dose of Lumitrace. The monitor shows the fluorescence intensity as it is being acquired and then displays the determined tGFR after data acquisition is completed.
Treatment groups
Trial outcomes
Primary outcomes
To validate the agreement of TGFR with mGFR in AKI patients at both the segmented and overall 0-12 hour levels.
Locations
Sponsors and contacts
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Bin Du
Lead sponsor
Peking Union Medical College Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: